Identity
- Trade Name
- Drill Sleeve Φ4.3 EUDAMED
- Device Name
- Non-sterile Orthopedic Manual Surgical Instruments EUDAMED
- Model / Reference
- F16BB-PA00177 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934635738110 EUDAMED
- Basic UDI-DI
- B-06934635738110 EUDAMED
- EMDN Code
- L098099 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Drill Sleeve Φ4.3 by Wuhan Mindray Scientific Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934635738110 | Class I | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 3dc485af-239b-4b6d-9efb-683c71d6e5ee 61 fields · synced Sep 17, 2026